FEATURED EDITORIAL
“I look from a supply-chain perspective,” says AI / supply-chain expert Tingling Dai, “discovery, development, manufacture ... until we put them into clinical use.” And that involves, he says, “keeping track of multiple stakeholders.”
- Essential Elements Of Technology Transfer
- Risk Tool Selection With ICH Q9(R1) In Mind
- AI, The Ghost In The Outsourcing Machine
- Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy
- In Year 20, “Biopharmaceutical” Remains The Same
- Guidelines For mRNA Drug Product Manufacturing And Quality Control
- Emerging Market Trends For APIs
GUEST COLUMNISTS
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Risk Tool Selection With ICH Q9(R1) In Mind
This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.
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Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy
If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.
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Guidelines For mRNA Drug Product Manufacturing And Quality Control
The lightning fast rise of mRNA raised the need for manufacturing standards and consensus on product quality attributes and test methods. This article provides perspective and insight on PQAs for mRNA vaccines and other mRNA-based products.
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Emerging Market Trends For APIs
The active pharmaceutical ingredient (API) market is estimated at $158 billion in 2023 and is projected to reach $232 billion by 2028. This article shares new market research on APIs, including an analysis of innovative and generic APIs, synthetic and biotech APIs, and more.
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Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development
The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.
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How Strategically Partnering With Academia Supports Biotech R&D Goals
For early-stage biotechs, partnering with leading academic institutions can help your firm cut costs and boost the returns on R&D investments while making key research and industry connections that can assist in the development, and ultimate commercialization, of your drug/therapy products.
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Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture
Considering the feverish pace of innovation in the field of AI/ML and the inevitable impact on drug development, we outline the documents and guidances that the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern.
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How To Implement Size Exclusion Chromatography And Mitigate HCP Risk
Research shows size-exclusion chromatography improves the host cell protein detection capabilities of liquid chromatography-tandem mass spectrometry. This guest article explores the strategy of using both to better understand HCP persistence in the purification process.
PHARMA OUTSOURCING WHITE PAPERS
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Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway
Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.
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Hot Melt Extrusion: Improving Solubility Of Poorly Soluble Compounds
As you create your hot-melt extrusion (HME) strategy to manufacture amorphous solid dispersions (ASDs), there are several considerations to ensure your plan is flexible, robust, and comprehensive.
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Formulation Research Strategy For Discovery- Stage New Drug Candidates
Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.
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Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization
There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.
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Switching From Vials To PFS And Intravenous To Subcutaneous Formulations
Learn about formulation development challenges for prefilled syringes as well as considerations for reducing the time it takes to launch safer, more convenient, and cost-effective products for the patient.
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Formulation Development Strategy For Early Phase Human Studies
Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE

CONTENT COLLECTIONS

More women are entering and making significant gains in our drug development and manufacturing outsourcing sector. In this e-book, Chief Editor Louis Garguilo highlights a few of these individuals, and takes account of the current environment for women who do enter our industry.
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